Summary & Overview
CPT 0502U: QuantiVirus HPV E6/E7 mRNA Test for Cervical Cancer
CPT code 0502U designates a Proprietary Laboratory Analyses (PLA) molecular diagnostic: the QuantiVirus™ HPV E6/E7 mRNA Test for Cervical Cancer from DiaCarta Inc. The assay identifies high–risk human papillomavirus (HPV) types in cervical cells by detecting E6/E7 mRNA markers via branched–chain capture hybridization and reports a binary positive/negative result. As a PLA code, 0502U applies exclusively to a single manufacturer's test, which has implications for coding specificity, payer recognition, and lab billing practices nationwide.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical application of the test, the service setting, and which major payers are included in the coverage discussion. The publication outlines typical benchmarks used in laboratory reimbursement reviews, payer policy considerations for PLA codes, and the clinical context for HPV E6/E7 mRNA testing in cervical cancer detection.
This summary is intended for a national audience of billing managers, lab directors, and policy analysts seeking clear information on the code's purpose, relevant payers, and the content areas covered in the full publication. Data not available in the input will be identified as such within the detailed sections.
Billing Code Overview
CPT code 0502U is a Proprietary Laboratory Analyses (PLA) code for the QuantiVirus™ HPV E6/E7 mRNA Test for Cervical Cancer from DiaCarta Inc. The test detects high–risk human papillomavirus (HPV) types in cervical cells by identifying E6/E7 mRNA markers using branched–chain capture hybridization and reports results as positive or negative for high–risk HPV.
Service Type: Molecular diagnostic laboratory test (Proprietary Laboratory Analysis)
Typical Site of Service: Clinical laboratory or reference laboratory
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Clinical & Coding Specifications
Clinical Context
A typical patient is a sexually active adult woman presenting for cervical cancer screening follow-up after an abnormal Pap test or positive high-risk HPV DNA screening, or for evaluation of persistent cytologic abnormalities. The clinical workflow begins in the outpatient gynecology clinic: a clinician (OB/GYN, family medicine, or women's health nurse practitioner) collects a cervical specimen during speculum exam using a cytobrush/collection device, places the sample in appropriate transport medium, and sends it to DiaCarta Inc. or an authorized reference lab. The lab performs the QuantiVirus™ HPV E6/E7 mRNA Test (0502U) using branched-chain capture hybridization to detect E6/E7 mRNA from high-risk HPV types and reports a binary result (positive/negative) for high-risk HPV. Results are routed back to the ordering provider who documents the finding, informs the patient, and determines next steps (surveillance, colposcopy, biopsy, or treatment) based on clinical guidelines and the patient’s history. Typical site of service is outpatient ambulatory clinic, physician office, or an independent clinical laboratory performing PLA testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Modifier not otherwise specified (proprietary) | Use only if required by payer for proprietary PLA tracking when no other modifier applies. |